Recruiting

Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients

ClinicalTrials.gov IDNCT06903819

PhasePHASE4

Enrollment90

SponsorTexas Tech University Health Sciences Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use, Depression, Post-traumatic Stress Disorder (PTSD)

About this study

The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD). The main questions it aims to answer are: Does ketamine reduce pain after surgery compared to standard anesthesia? Does ketamine reduce the amount of opioids patients need for pain control? Does ketamine improve symptoms of depression and PTSD after orthopedic trauma? Researchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery. Participants will: Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery. Report their pain using a simple pain scale (Visual Analog Scale, VAS). Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery. Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery. Attend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery

Interventions

Drug: Ketamine — Participants in this group will receive a single intravenous (IV) dose of ketamine at 0.5 mg/kg, administered within 30 minutes of anesthesia induction during surgical fixation for musculoskeletal trauma. The purpose of the intervention is to evaluate ketamine's effect on postoperative pain, opioid consumption, and psychological recovery, including symptoms of depression and post-traumatic stress disorder (PTSD).
Drug: standard general anesthesia — Participants in this group will receive standard general anesthesia during surgical fixation for musculoskeletal trauma. No ketamine will be administered. This group serves as a comparison to evaluate the effects of ketamine on pain, opioid use, and psychological recovery.

Primary outcomes

Pain Intensity (VAS) (1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.)

Eligibility information

Inclusion Criteria: * Adults aged 18-65 * Undergoing acute operative fixation for musculoskeletal trauma * Injury Severity Score (ISS) greater than 15 * Ability to provide informed consent (or consent provided by a legally authorized representative) Exclusion Criteria: * Age under 18 or over 65 * Use of ketamine for preoperative or postoperative sedation * Known allergy or contraindication to ketamine * Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD * Severe psychiatric conditions or psychotic features * History of dementia or glaucoma * Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months

Study locations

Texas Tech University Health Sciences Center Lubbock, Lubbock, Texas 79415 United States
University Medical Center, Lubbock, Texas 79415 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.